Synopsis: Drug company reports of gifts. Requires pharmaceutical
manufacturers to report information concerning gifts and payments that
are made to a person who prescribes or purchases prescription drugs.
Excludes certain gifts and payments from disclosure. Provides that
failure to disclose required information is a Class A infraction. Repeals
a definition superseded by this act.

Effective: July 1, 2003.

Welch

January 23, 2003, read first time and referred to Committee on Public Health.

Introduced

First Regular Session 113th General Assembly (2003)

PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
Constitution) is being amended, the text of the existing provision will appear in this style type,
additions will appear in this style type, and deletions will appear in thisstyletype.
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provision adopted), the text of the new provision will appear in this style type. Also, the
word NEW will appear in that style type in the introductory clause of each SECTION that adds
a new provision to the Indiana Code or the Indiana Constitution.
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between statutes enacted by the 2002 Regular or Special Session of the General Assembly.

HOUSE BILL No. 1909

A BILL FOR AN ACT to amend the Indiana Code concerning
health.

Be it enacted by the General Assembly of the State of Indiana:

SOURCE: IC 16-18-2-37.5; (03)IN1909.1.1. -->
SECTION 1.
IC 16-18-2-37.5
IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2003]: Sec. 37.5. "Board", for purposes of
IC 16-42-25
, has the meaning set forth in
IC 16-42-25-2.

compounding, encapsulating, entableting, or other process; or
(2) packages or repackages legend drugs.
(b) The term does not include pharmacists or practitioners (as
defined in section 288(a) and 288(c) of this chapter) in the practice of
their profession.

SOURCE: IC 16-18-2-280.5.; (03)IN1909.1.4. -->
SECTION 4.
IC 16-18-2-280.5.
IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2003]: Sec. 280.5. "Pharmaceutical
marketer", for purposes of
IC 16-42-25
, has the meaning set forth
in
IC 16-42-25-3.

SOURCE: IC 16-42-25; (03)IN1909.1.5. -->
SECTION 5.
IC 16-42-25
IS ADDED TO THE INDIANA CODE
AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2003]: Chapter 25. Drugs: Pharmaceutical Manufacturer Marketing
Report
Sec. 1. This chapter does not apply to a wholesale drug
distributor or distributor's representative who promotes or
markets the services of the wholesale drug distributor in
connection with a legend drug.
Sec. 2. As used in this chapter, "board" refers to the Indiana
board of pharmacy established by IC 25-26-13-3.
Sec. 3. As used in this chapter, "pharmaceutical marketer"
means a person who, while employed by or under contract to
represent a manufacturer, engages in pharmaceutical detailing,
promotional activities, or other marketing of a legend drug in
Indiana to any physician, hospital, health care facility, pharmacist,
health benefit plan administrator, or any other person authorized
to prescribe, dispense, or purchase a legend drug.
Sec. 4. This chapter does not require a manufacturer to disclose
the following:
(1) Drug samples intended to be distributed to patients.
(2) The payment of reasonable compensation and
reimbursement of expenses in connection with an approved
clinical trial conducted in connection with a research study
designed to answer specific questions about vaccines, new
therapies, or new ways of using known treatments.
(3) Any gift, fee, payment, subsidy, or other economic benefit,
the value of which is less than twenty-five dollars ($25).
(4) Scholarships or other support for medical students,
residents, and fellows to attend a significant educational,
scientific, or policymaking conference of a national, regional,
or specialty medical or other professional association if the

recipient of the scholarship or other support is selected by the
association.
Sec. 5. (a) Before October 15 of each year, each manufacturer
shall disclose, for the preceding twelve (12) month period ending
June 30, to the board the value, nature, and purpose of any gift,
fee, payment, subsidy, or other economic benefit provided in
connection with detailing, promotional or other marketing
activities by the manufacturer or through the manufacturer's
pharmaceutical marketers to any physician, hospital, nursing
home, pharmacist, health benefit plan administrator, or any other
person authorized to prescribe, dispense, or purchase legend drugs
in Indiana.
(b) Each manufacturer subject to this chapter shall annually
disclose to the board the name and address of the individual
responsible for the manufacturer's compliance with the provisions
of this chapter.
Sec. 6. (a) The board shall provide to the office of the attorney
general complete access to the information disclosed under section
5 of this chapter.
(b) Before February 1 of each year, the office of the attorney
general shall report to the general assembly and the governor on
the manufacturers' disclosures made the preceding year under this
chapter.
Sec. 7. (a) The board and the office of the attorney general shall
keep confidential all trade secrets (as defined by
IC 24-2-3-2
)
identified under this chapter.
(b) The disclosure form prescribed by the board must allow the
manufacturer to identify any information that is a trade secret.
Sec. 8. (a) A person who violates this chapter commits a Class
A infraction.
(b) The attorney general may bring an action for injunctive
relief, costs, and attorney's fees against a manufacturer that fails
to disclose information as required under section 5 of this chapter.
(c) Each failure to disclose information required under section
5 of this chapter constitutes a separate violation.

licenses;
(3) refuse to issue, deny, suspend, or revoke a license or permit or
place on probation or fine any licensee or permittee under this
chapter;
(4) regulate the sale of drugs and devices in thestateof Indiana;
(5) impound, embargo, confiscate, or otherwise prevent from
disposition any drugs, medicines, chemicals, poisons, or devices
which by inspection are deemed unfit for use or would be
dangerous to the health and welfare of the citizens of the state of
Indiana; the board shall follow those embargo procedures found
in
IC 16-42-1-18
through
IC 16-42-1-31
, and persons may not
refuse to permit or otherwise prevent members of the board or
their representatives from entering such places and making such
inspections;
(6) prescribe minimum standards with respect to physical
characteristics of pharmacies, as may be necessary to the
maintenance of professional surroundings and to the protection of
the safety and welfare of the public;
(7) subject to
IC 25-1-7
, investigate complaints, subpoena
witnesses, schedule and conduct hearings on behalf of the public
interest on any matter under the jurisdiction of the board;
(8) prescribe the time, place, method, manner, scope, and subjects
of licensing examinations which shall be given at least twice
annually; and
(9) administer the collection of information from
pharmaceutical manufacturing companies under
IC 16-42-25
;
and (10) perform such other duties and functions and exercise such
other powers as may be necessary to implement and enforce this
chapter.
(b) The board shall adopt rules under
IC 4-22-2
for the following:
(1) Establishing standards for the competent practice of
pharmacy.
(2) Establishing the standards for a pharmacist to counsel
individuals regarding the proper use of drugs.
(c) The board may grant or deny a temporary variance to a rule it
has adopted if:
(1) the board has adopted rules which set forth the procedures and
standards governing the grant or denial of a temporary variance;
and
(2) the board sets forth in writing the reasons for a grant or denial
of a temporary variance.

SOURCE: ; (03)IN1909.1.8. -->
SECTION 8. [EFFECTIVE JULY 1, 2003] (a) The definitions in
IC 16-42-25
, as added by this act, apply to this SECTION.
(b) Notwithstanding
IC 16-42-25-5
(a), as added by this act, the
initial disclosure shall be made before October 15, 2004, for the
preceding twelve (12) month period ending June 30, 2004.
(c) Notwithstanding
IC 16-42-25-5
(b), as added by this act, each
manufacturer subject to the provisions of this chapter shall
disclose to the board, before October 15, 2003, the name and
address of the individual responsible for the manufacturer's
compliance with
IC 16-42-25, as added by this act.
(d) This SECTION expires July 1, 2006.